Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Paclitaxel Adverse Reaction
- Peripheral Arterial Disease
- Safety Issues
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Retrospective
Participation Requirements
- Age
- Between 66 years and 125 years
- Gender
- Both males and females
Description
This is an observational retrospective cohort study using claims data to evaluate the long-term safety of paclitaxel-coated devices compared with non-drug coated devices for femoropopliteal artery revascularization, with median follow-up time for the population surpassing 5 years. A series of supple...
This is an observational retrospective cohort study using claims data to evaluate the long-term safety of paclitaxel-coated devices compared with non-drug coated devices for femoropopliteal artery revascularization, with median follow-up time for the population surpassing 5 years. A series of supplemental sensitivity analyses will be conducted to assess and mitigate the potential for unmeasured confounding and to determine the impact of repeat interventions and paclitaxel exposure on survival. Finally, sub-group analyses will be performed to investigate whether there is differential safety of paclitaxel-coated devices across different patient profiles.
Tracking Information
- NCT #
- NCT04496544
- Collaborators
- Medtronic
- Philips Healthcare
- Bard Peripheral Vascular, Inc.
- Boston Scientific Corporation
- Cook Medical
- Investigators
- Principal Investigator: Eric A Secemsky, MD Beth Israel Deaconess Medical Center Principal Investigator: Robert W Yeh, MD Beth Israel Deaconess Medical Center
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